Clinical trial · Interventional
Improving Sleep in Cancer Patients: A Feasibility Trial
Improving Sleep in Cancer Patients: A Feasibility Trial of Implementing Cognitive Behavioral Therapy for Insomnia During Cancer Treatments
NCT03561064CI-TRIAL-00038066ISCAPcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to determine if CBT-I (cognitive behavioral therapy for insomnia) is a feasible treatment for insomnia in individuals undergoing cancer treatment.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
| Insomnia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CBT-I | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Receiving CBT-I
- description
- This is a single arm study. All participants will receive CBT-I (cognitive behavioral therapy for insomnia).
- interventionNames
- Behavioral: CBT-I
Primary outcomes (1)
- measure
- Change of the score on the Insomnia Severity Index (ISI)
- timeFrame
- baseline and at 19th week
- description
- The ISI assesses the severity of insomnia symptoms and subjective daytime impairments.
Secondary outcomes (4)
- measure
- Change of diary-assessed sleep onset latency
- timeFrame
- baseline and at 19th week
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. 18+ years of age 2. have insomnia disorder (SOL or WASO greater than 30 minutes for more than 6 nights in two weeks + daytime impairments) 3. are diagnosed with gastro-intestinal cancer; 4. have life expectancy \> 6 months; 5. are fully ambulatory indicated by the provider-rated score of greater than 2 on the Eastern Cooperative Oncology Group (ECOG) performance measure; 6. will complete cancer treatments in no less than seven weeks, allowing for two weeks of assessments and five weeks of CBT-I; 7. are English-speaking and able to provide voluntary, written consent. Exclusion Criteria: 1. unmanaged sleep apnea indicated by the scores on the STOP-BANG Questionnaire suggesting high risk for sleep apnea and not receiving any sleep apnea treatment; 2. other sleep disorders; 3. bipolar disorder; 4. unmanaged serious mental illnesses; 5. suicidal ideation/intent/plan; 6. unstabilized pharmacological treatment for insomnia; 7. night-shift employment.
References
Publications (0)
Data not yet available
No reference posted for this study.